Surgical stapling instrument

ABSTRACT

A stapler for stapling a tubular structure to another structure. The stapler has an anvil which is expandable from a collapsed position to an expanded position. The stapler has a recess which receives at least a portion of the tubular structure and a shoulder which receives an everted end of the tubular structure. A first actuator moves the anvil relative to the shoulder for compressing the structures which are to be stapled together. A second actuator is used for driving the staples through the structures to be stapled together.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of Ser. No. 08/550,285 filedOct. 31, 1995, pending, which is a continuation-in-part of Ser. No.08/261,167 filed Jun. 11, 1994, now abandoned.

FIELD OF THE INVENTION

The invention relates generally to surgical stapling appliances and moreparticularly to an improved apparatus and method for the anastomoticsurgical stapling of luminal organs, such as vascular lumens.

BACKGROUND OF THE INVENTION

Various instruments are known in the prior art for end-to-end andend-to-side anastomotic surgical stapling together of parts of thealimentary canal (i.e., esophagus, stomach, colon, etc.). Theseinstruments employ staple cartridges, generally in the shape of a hollowcylinder, of different sizes to accommodate tubular organs of varyingdiameters. End-to-end and end-to-side anastomoses are achieved by meansof at least one ring of surgical staples.

The traditional technique for surgical stapling anastomosis is toposition the stapling cartridge within the tubular organ to be stapled.The cut end of the tubular organ is inverted (i.e., folded inwardly)over the annular end of the staple cartridge creating an invertinganastomosis upon stapling. An essential requirement of the invertinganastomotic technique is the incorporation of knives within the staplecartridge housing to trim excess tissue from the anastomotic connection.

The prior art anastomotic stapling instruments form generally circularanastomotic connections, and have been largely limited to alimentaryorgans. With respect to end-to-side vascular anastomosis, circularconnections, rather than an elliptical connections, are sometimesdisadvantageous as they are less physiologic or natural. This unnaturalconnection may create turbulence in the blood flow as it courses throughthe anastomosis, damaging the intima (i.e., inner wall) of the bloodvessel and predisposing it to forming blood clots.

In the present state of the art, end-to-end and end-to-side anastomosisbetween blood vessels have typically been accomplished by hand-sewnsuturing techniques. These techniques are time consuming, not asreliable as stapling, and subject to greater human error than stapling.Current stapling instruments used for alimentary canal are nor suitable,however, for vascular anastomosis due to their large sizes and inabilityto provide non-circular and low turbulence anastomoses. A typical priorart instrument has a circumference of approximately 8 cm (3 in), far toothick to accommodate coronary arteries and veins, which havecircumferences ranging from 0.50 to 1.0 cm and from 1.5 to 2.5 cm,respectively.

An additional drawback of prior stapling instruments is the inability toprovide an everted (i.e., folded outwardly) anastomosis. An invertedvascular anastomosis would expose the cut ends of the blood vessels tothe vessel lumen and could lead to the formation of blood clots. Forthis reason, hand-sewn everted anastomoses for vascular connections arepreferable, despite time and reliability drawbacks.

Accordingly, it is a general object of the present invention to providean improved instrument and method for vascular anastomosis.

It is also an object of the present invention to provide a surgicalstapling instrument small enough to accommodate vascular lumens.

Another object of the present invention is to provide a surgicalstapling instrument for everted anastomosis.

Another object of the present invention is to provide a method forsurgical stapling that does not require the removal of excess tissuefrom the anastomotical connection.

Still another object of the present invention is to provide aninstrument and method for vascular anastomosis that is lesstime-consuming and more reliable than the prior art.

SUMMARY OF THE INVENTION

The present invention provides a novel instrument and method forvascular anastomoses which overcomes the drawbacks of prior art designsand achieves the aforesaid advantages.

Very generally, the surgical stapling instrument of the presentinvention is for stapling a tubular tissue structure having at least onedistal end to a luminal structure, such as a vascular lumen or anothertubular tissue structure. The instrument comprises a rod having acircumference sufficient to pass within the tubular tissue structure, ananvil mounted on the rod, and a generally tubular staple cartridge forcontaining a plurality of staples. The anvil has an array of stapledeforming means thereon and is of a size sufficient to pass through asurgically formed opening in and to be accommodated within the luminalstructure. The inner passage of the staple cartridge is sufficient toaxially accommodate the tubular tissue structure between the rod and theinner surface of the staple cartridge, and sufficient to allow thestaple cartridge to be moved axially along the rod. The staple deliveryend of the staple cartridge is positioned toward the staple deformingmeans of the anvil and has an outer dimension small enough so that thetubular tissue structure can be everted thereover. A clamping mechanismsecures the everted portion of the tubular tissue structure and theluminal structure adjacent to the surgically formed opening between thestaple cartridge and the anvil. A plurality of staples may then beejected to pass through the everted portion of the tubular tissuestructure and the luminal structure to engage the staple deforming meansto deform the staples and create a bond between the tubular tissuestructure and the luminal structure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a fragmentary side elevation view, in cross section, of oneembodiment of the anastomosis device constructed in accordance with thepresent invention and illustrating an end of the tubular tissuestructure everted over the device end.

FIG. 2 is a front elevation view, in cross-section, of the anastomosisdevice taken substantially along the plane of the line 3--3 in FIG. 1

FIG. 3 is a rear elevation view, in cross-section, of the anastomosisdevice taken substantially along the plane of the line 2--2 in FIG. 1

FIG. 4 is a side elevation view, in cross-section, of the anvil of theanastomosis device taken substantially along the plane of the line 4--4in FIG. 3

FIG. 5 is a front elevation view, in cross-section, of an alternativeembodiment of FIG. 3 illustrating a tear drop-shaped configuration.

FIG. 6 is a rear elevation view, in cross-section, of the anvil of thealternative embodiment of FIG. 5 taken substantially along the plane ofthe line 2--2 in FIG. 1.

FIG. 7 is an exploded top perspective view, partially cut-away, of theanastomosis device of FIG. 1.

FIG. 8 is an enlarged, exploded, top perspective view, partiallycut-away, of a staple cartridge assembly of the anastomosis device ofFIG. 1.

FIG. 9 is an enlarged, side elevation view, in cross-section, of theanvil and staple cartridge assembly of the anastomosis device of FIG. 1illustrating the deformation of a staple.

FIGS. 10-12 is a sequence of top perspective views illustrating theloading of a tubular tissue structure in the anastomosis device of FIG.1.

FIG. 13 is an enlarged, side elevation view, in partial cross-section,showing the positioning of the anvil of the anastomosis device through aluminal structure.

FIG. 14 is a reduced top perspective view of the anastomosis device ofFIG. 1 mounted to the luminal structure.

FIG. 15 is a reduced top perspective view of the tubular tissuestructure anastomotized to the luminal structure using the anastomosisdevice of FIG. 1.

FIG. 16 is a front elevation view of a grafted tubular tissue structureanastomotized to a coronary artery of the heart through the anastomosisdevice of FIG. 1.

FIG. 17 is an exploded top perspective view of an alternative embodimentof the anastomosis device of the present invention.

FIG. 18 is a fragmentary, enlarged top perspective view of a staplecartriage assembly of the alternative embodiment anastomosis device ofFIG. 17.

FIG. 19 is an end view of the staple cartridge assembly of FIG. 18.

FIGS. 20-22, 24, 25, 27 and 28 is sequence of top perspective viewsillustrating the application of the alternative embodiment anastomosisdevice of FIG. 17 for proximal anastomosis of the grafted tubular tissuestructure to the ascending aorta.

FIGS. 23 and 26 is a sequence of fragmentary, top perspective viewsillustrating the loading of a tubular tissue structure in thealternative embodiment anastomosis device of FIG. 17.

FIG. 29 is a cross-sectional view of another stapler.

FIG. 30 is a cross-sectional view of a distal end of the stapler of FIG.30.

FIG. 31 is a cross-sectional view of FIG. 30 along line I--I.

FIG. 32 is a cross-sectional view of FIG. 30 along line II--II.

FIG. 33 shows a staple.

FIG. 34 is a top view of the staple.

FIG. 35 is a cross-sectional view of a rod having a graft attachedthereto.

FIG. 36 shows the distal end of the graft everted around the shoulder.

FIG. 37 shows the staples penetrating the graft and engaging an anvil.

FIG. 38 is a longitudinal cross-sectional vice of yet another stapler.

FIG. 39 shows the anvil in a collapsed position.

FIG. 40 shows the anvil in an expanded position.

FIG. 41 is a cross-sectional view of FIG. 38 along line III--III.

FIG. 42 is a cross-sectional view of FIG. 39 along line IV--IV.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIGS. 1-7, there is shown a structural embodiment of thepresent invention which is best suited for anastomotic stapling of atubular vessel having two distal or untethered ends. As will beevidenced by the detailed description below, this embodiment, i.e.,distal stapler, is ideal for use during cardiopulmonary bypass surgeryfor making the primary anastomotic connection of a bypass vein to acoronary artery or to the aorta.

Referring now to FIG. 1, a portion 10 of the wholly configured distalstapler of the present invention, as shown in FIG. 7, comprises anelongated central rod 12 with anvil 14 mounted at its distal end 16.Anvil 14 is in the form of a circular, elliptical or tear drop-shapeddisk and is mounted, by suitable means such as welding, to the end ofcentral rod 12 transversely thereof and at the center of the anvil. Theedges of anvil 14 are beveled or otherwise generally rounded to enableanvil 14 to slip easily through incisions in vascular walls--much like abutton through a button hole.

The central rod 12 has a circumference sufficient to permit the rod toaxially extend through a tubular vessel, indicated in phantom at 20, tobe stapled. Central rod 12 also axially extends within tubular housing22, driver pins 24 and staple cartridge 26, together forming acontiguous shaft 28 having an inner circumference sufficient toaccommodate tubular vessel 20 sandwiched between them and central rod12. Staple cartridge 26 has an outer circumference sufficient toaccommodate everted end 34 of tubular vessel 20. Lip 36 of cartridge 26is tapered to facilitate eversion of tubular vessel 20. Anvil 14 hascircumference of a size equivalent to the outer circumference of staplecartridge 16.

Circumferences of vascular vessels range from 0.50 to 1.0 cm forcoronary arteries and from 1.5 to 2.5 cm for veins. Accordingly, allcircumferences, discussed above, of stapler 10 are of a size tooptimally coaxially accommodate the vein to be stapled.

The end of central rod 12 opposite anvil 14 is centrally mounted,preferably welded, on a cylindrical base 40 which extends coaxiallywithin tubular housing 22 (as shown in FIG. 7 by reference number 106)and has a circumference sufficient to be slidable within tubular housing22. The accommodated tubular vessel 20 extends along central rod 12 tocylindrical base 40. Provided on the surface of central rod 12 proximalto base 40 is circumferential groove 44 for facilitating the securing oftubular vessel 20 to rod 12 by means of string 46. Similarly,circumferential groove 48 and string 50 are provided to secure evertedend 34 of vessel 20 to staple cartridge 26. An alternative embodiment ofstaple cartridge 26 for securing an everted vein comprises tiny hooksaround the circumference at end 36 of the cartridge. Other suitablemeans for accomplishing the securing function may be used as well.

Referring now to FIG. 2, there is shown a cross-sectional view ofstapler 10 of the present invention in the direction of arrows 2--2 ofFIG. 1. Here, the staple delivery end 60 of a circular staple cartridgeis illustrated encasing a circular array of staple delivery means orstaple shafts 62. The present invention is not limited to a singlestaple shaft array, however. It is commonly known in the art to employ aplurality of concentric arrays or rows of staple shafts for anastomoticprocedures. Extending from staple shaft array 62, is an array of narrowchannels 68, each narrow channel corresponding to each staple shaft.Channel array 68 is used solely for manufacturing purposes and is not anecessary element of the invention. Central rod 64 and its base 66 areaxially and centrally located within the cylindrical staple cartridge60.

FIG. 3 shows the underside view of anvil 70 in the direction of arrows3--3 of FIG. 1. The anvil 70 has an array 74 of means for deformingstaples. Central rod attachment 72 is centrally located on anvil 70which provides an array of staple deforming means 74, comprised here ofan array of recess pairs, for bending staples projected fromcorresponding array of staple shafts 62 of the staple cartridge of FIG.2.

Depicted in FIG. 4 is a cross-sectional view of anvil 70 in thedirection of arrows 4--4 of FIG. 3. Each recess pair 76 is curved tobend staple legs radially inward. The projected staples can be made tobend radially inward or radially outward depending on the spacing 78between the recess of each paired recess 76. Alternatively, each recesscan be positioned orthogonal to its present position to bend the staplelegs at right angles to their axis of projection.

Although the present invention is primarily described and depicted asforming staple bonds that are circular and as having componentcircumferences that are circular, other embodiments are realized forforming staple bonds having elliptical, tear drop or other generallyoval circumferences. Accordingly, the anvil and associated staple recessarray, and the cartridge housing and associated staple shaft array ofthese alternative stapler embodiments have circumferences in the shapeof the desired staple bond. For example, FIGS. 5 and 6 illustrate ananvil and staple cartridge, respectively, having tear-drop shapedcircumferences.

FIG. 5 shows a cross-sectional view of a tear-drop shaped staplecartridge. The staple delivery end 80 of the staple cartridge isillustrated encasing a tear drop array of staple delivery means orstaple shafts 82. Extending from staple shaft array 82, is an array ofnarrow channels 84, each narrow channel corresponding to each stapleshaft. Channel array 84 is used solely for manufacturing purposes and isnot a necessary element of the invention. Central rod 86 and its base 88are coaxially and centrally located within the cylindrical portion ofdear drop staple cartridge 80.

FIG. 6 shows the underside view of a tear drop shaped anvil 90. Centralrod attachment 92 is centrally located on the circular portion of anvil90 which provides an array of staple deforming means comprised of recesspairs 94 for bending staples projected from corresponding array ofstaple shafts 82 of the staple cartridge of FIG. 5.

Referring now to FIG. 7, there is shown stapler 100 of the sameembodiment depicted in FIGS. 1-4. A tubular housing 102 coaxiallycontains central rod 104 and rod base 106, the end of central rod 104opposite that of anvil 114 being suitably mounted, such as by welding,to rod base 106 (connection not shown). Threadedly mounted to andextending perpendicular from rod base 106 is a short stem 108,positioned at approximately half the length of base 106. The top of stem108 has cylindrical knob 110 transversely mounted. Stem 108 is moveablewithin narrow channel 112, cut within housing 102 and running parallelto the axis traveled by central rod 104 and rod base 106. Channel 112limits the rotational movement of stem 108 and thereby maintains aproper radial orientation between anvil 114 and staple cartridge 116during reciprocation.

Weldedly mounted to and protruding perpendicularly from cylindrical face118 of housing 102 and paralleling rod 104 is cylindrical array ofstaple driver pins 120, all drivers pins being identical and each havingthe form of a solid parallelogram. Staple cartridge 116 encases, fromend to end, cylindrical array of hollow staple shafts 122 which holds aplurality of preloaded staples (not pictured). All shafts 122 areidentical and each has height and width dimensions such that acorresponding staple driver pin 120 is slidable therein.

In order to have an optimally functioning stapler, it is necessary tomaintain a clean and clear passageway for central rod 104, base 106 andstaple shafts 122. Accordingly, one embodiment of the present inventioncomprises a disposable cartridge which is disposed of and replaced afterone anastomotic stapling. Another embodiment provides a slidable sleevearound the driver pin array to prevent blood and tissue from gettingcaught therein.

For anastomosis to be successful, it is imperative not to injure theliving tissue being stapled by overcompressing it between anvil 114 andstaple cartridge 116 or by a staple bond that is exceedingly tight.Accordingly, overcompression of the tissue is prevented in the presentinvention by limiting the length of driver pins 118. Other embodimentsare known in the prior art for accomplishing this objective. Forexample, U.S. Pat. No. 4,575,468 employs mutually coacting stops locatedon the inner surface of a tubular housing and on the surface of acoaxial rod to provide variable degrees of engagement between tissues tobe stapled so as to ensure against overcompression of the tissue. Aspring-loaded engagement between the rod and tubular housing is alsoapplicable for the present invention. Other means suitable for thispurpose will be apparent to those having ordinary skill in the art.

Finally, FIG. 7 illustrates threaded end 124 of rod base 106 whichextends beyond the length of housing 102 to threadedly engage withcylindrical nut 126 which has internally threaded throughbore 120extending the full length of cylindrical nut 126 to allow end 124 toexit therethrough.

FIGS. 8 and 9 illustrate the mechanical interaction between the stapledriver, staple cartridge and anvil upon engagement. FIG. 8 illustratesstaple driver array 200 mounted on face 202 of tubular housing 204slidably engaged within staple shaft array 206 of staple cartridge 208.Staple array 210 is projected from staple cartridge 208 and through thetissues to be stapled (not shown). FIG. 9 shows a close-up of a staplebeing driven by driver pin 252 and projecting through cartridge 254through tissues 256 and 258. The legs 260 and 262 of staple 250 thenengage with and bend along the curved recesses 264 and 266,respectively, of anvil 268 to form a bond between tissues 256 and 258.

Referring now to FIGS. 10-16, with like numbers referring to likeelements, there is illustrated the steps of the anastomotic procedureusing the structural embodiment described above. Now referring to FIG.10 specifically, the anvil-headed end of rod base 302 is inserted intotransected vein 304 having a length in the range of 10-18 cm (4-7inches). End 308 (the end to be stapled) of vein 304 is positionedproximate to anvil 306. Opposing end 310 of vein 304 is tied with string312 to central rod 314 at a circumferential depression (not shown)proximate to base 302.

FIG. 11 shows the step of inserting central rod 314 with attached vein304 into staple cartridge 318 and tubular housing 316 such that staplecartridge 318 is proximate to anvil 306. FIG. 12 illustrates the nextseveral steps of the method of the present invention which can beperformed in any order. The end of vein 304 is everted over staplecartridge 318 and tied with string 320 securing it to staple cartridge318 (covered by vein 304). Threaded stem 322 of cylindrical knob 324 isthreadedly engaged with a threaded bore (not shown) base 302, the borebeing aligned with narrow channel 326. Cylindrical nut 328 is threadedlyengaged with the threaded end 300. As indicated in FIG. 13, anvil 306 ispositioned within lumen 330 of vascular artery 332 via incision 334. Across-section of a portion of vein 304 is shown everted over the stapledelivery end of staple cartridge 318.

In FIG. 14, central rod 314 (not visible) and rod base 302 (not visible)are optimally coaxially positioned within tubular housing 316 by meansof sliding knob 324 along channel 326 toward vascular artery 332. Nut328 is rotated in a clockwise direction to engage it with tubularhousing 316 causing rod base 302 to become rigidly interconnected withnut 328. As the clockwise turning continues, rod base 302 is drawnthrough the bore in nut 328, bringing the staple cartridge 336 and anvil306 within artery 332 together. An embodiment employing mutuallycoacting stops (not shown) would, at this point, be at the firstcoacting position or the "loaded" position. The clockwise motion iscontinued so that everted vein 304 engages with the wall of artery 332and until the staple drivers (not visible) are actuated, driving thestaples (not visible) through the tissues to create a bond 338 (FIG.15). If mutually coacting stops are employed, the configuration would bein the "firing" position.

Finally, FIG. 16 illustrates heart 350 having aorta 352, pulmonaryartery 354, right atrium 356, right ventricle 358, left ventricle 360,left atrial appendage 362, right coronary artery 364, left anteriordescending artery 368, and diagonal artery 370. Here, vein 304 has beenanastomotically stapled to left anterior descending artery 368.

To complete the anastomotic procedure of the bypass vein 304, theunstapled end of the anastomotized vein 304 must now be connected toaorta 352. However, another structural embodiment of the presentinvention, referred to as the "proximal" stapler, is needed since theembodiment described above, i.e., the "distal" stapler, requires thevein to have two distal or untethered ends. Accordingly, FIGS. 17-28describe a structure and method thereof for a second embodiment of thepresent invention which is suited for the anastomotic stapling of atubular vessel having only one distal end, the other end having alreadybeen anastomotically stapled.

Referring now to FIGS. 17-19, with like numbers referencing likeelements, there is shown anastomotic stapler 400 having handle 402 withelongated vessel rod 404 and elongated driver rod 406 mountedperpendicularly to handle face 408 and parallel to each other, bothbeing of approximately the same length. Vessel rod 404 has a centrallymounted generally circular anvil 410. Vessel rod 404 has a circumferencesufficient to coaxially accommodate a tubular vessel (not shown) to bestapled to the aorta. Driver rod 406, having threaded end 412 and handle414, extends through bore 416 of handle 402.

Stapler 400 also comprises staple cartridge 418, enlarged in FIG. 18 forpurposes of describing its detail. Referring then to FIG. 18, there isshown the staple cartridge of FIG. 17 in its open position having topand bottom units 420 and 422, respectively. Units 420 and 422 areengaged at one side by hinge 424 which allows cartridge 418 to be openedand closed. Staple cartridge 418 has two parallel bores 426 and 428 withinner circumferences sufficient to coaxially accommodate vessel rod 404with a coaxially accommodated vein (not shown) and driver rod 406,respectively. Staple delivery end 430 extends from staple cartridge 418along the axis of bore 426 to accommodate the everted end of a vein tobe stapled. Bore 428 is internally threaded to be threadedly engagablewith driver rod end 412.

For a proper fit between units 420 and 422, a detent-recess pair isprovided having detent 432 extending from inner surface 434 of top unit420 which mates with recess 436 within inner surface 438 of bottom unit422. To secure closing, a curved clip 440 is provided to fit aroundcylindrical casing 442 of bore 428.

When in a closed position, staple cartridge 418 has cylindrical stapledelivery means or staple shaft array (not shown) encased in stapledelivery end 430 which mates with cylindrical driver pin array 444mounted on driver 446. Both the hollow shafts and the solid driver pinshave height and width measurements that allow them to be slidablyengageable with each other. Driver 446 is slidable along surface 448 oftop unit 420 and surface 450 of bottom unit 422 to the point ofengagement with shoulder 452 of top unit 420 upon which driver pin array444 becomes engaged within the staple shaft array, projecting preloadedstaples from the end of staple delivery end 430. Shoulder 452 limits theengagement of driver pin array 444 so that the tissue being stapled isnot overcompressed. Modifications of the this embodiment can employmutually coacting stops or spring-loaded type configurations between thedriver and staple cartridge to prevent against overcompression of thetissue.

FIG. 19 shows a front view of staple cartridge 418 in its closedposition with top unit 420 engaged with bottom unit 422. Clip 440securely fits around cylindrical casing 442. Staple deforming end orstaple shaft array 454 is shown on the face of staple delivery end 430.

FIGS. 20-28, with like numbers referencing like elements, depict thevarious steps of the anastomotic procedure using the structuralembodiment in FIGS. 17-19 described above. Referring now to FIG. 20,vessel rod 500 is inserted through aorta 502 of heart 504 via incisions506 and 508 on opposing walls of aorta 502 such that anvil 510 iscentrally positioned within aorta 502.

In FIG. 21, the end of vessel rod 500 is then inserted into the distalend of vein 512 with anvil 510 still centrally positioned within aorta502. Next, as shown in FIG. 22, vessel rod 500 with accommodated vein512 is positioned within the corresponding bore 514 in open staplecartridge 516. Rod 500 and vein 512 should be positioned such that asufficient length of distal end 518 of vein 512 extends beyond the endof cartridge 516 such that distal end 518 can be everted overcylindrical sleeve 520 of cartridge 516 (See FIG. 23). Once vein 512 hasbeen optimally positioned, staple cartridge 516 is clamped around it andsecured with clip 522, illustrated in FIG. 24. Now, distal end 518 ofvein 512 is everted over sleeve 520 and is securely tied with string524.

Referring now to FIG. 25, driver rod 526 is slid into bore 528 of handle530 and then threadedly engaged with bore 532 of staple cartridge 516.FIG. 26 shows a close-up of staple cartridge 516 as it appears in itsclosed position.

Moving now to FIG. 27, there is shown driver handle 534 rotated in aclockwise direction, bringing together anvil 510 and cylindrical sleeve520. The clockwise rotation is continued until the aorta wall 502 isengaged with the distal end 518 of vein 512 upon which the staple driverpins (not visible) are fully engaged within each of the correspondingstaple shafts (not visible), driving the staples (not visible) throughthe engaged tissue to create anastomoric bond 536 between aorta 502 andvein 512 (See FIG. 28).

Referring to FIG. 29, another stapler 600 is shown. The stapler 600advantageously provides an actuator 602 for compressing the tissuelayers to be stapled and a trigger 604 for firing the staples (notshown). By providing both the actuator 602 and trigger 604, the amountof tissue compression can be controlled independent of staple firing.

The stapler 600 includes a handle 606 with the actuator 602 beingrotatably coupled to the proximal end of the handle 606. The actuator602 has a groove 608 which engages a set screw 610 in the handle 606 sothat the actuator 602 can only rotate relative to the handle 606. A rod612 is threadably coupled to the handle 606 so that rotation of theactuator 602 moves the rod proximally and distally. The rod 612 extendsthrough a housing 614 and an anvil 616 is connected to the distal end ofthe rod 612. As will be discussed in further detail below, the actuator602 is rotated to move the anvil 616 relative to a shoulder 618 of thehousing 614 for compressing the tissue layers to be stapled.

The trigger 604 is pivotally coupled to the handle 606 and actuation ofthe trigger 604 fires the staples (not shown) as will be described infurther detail below. The trigger 604 engages a driver 620 which isbiased toward the position of FIG. 29 by a spring 622. A stop 624 limitsrotation of the trigger 604 beyond the position in FIG. 29. The driver620 contacts and drives a shaft 626 which extends toward the distal end.The driver 620 preferably has a throughhole 628 having a squarecross-sectional shape (not shown) through which the rod 612 extends. Therod 612 has a complementary square cross-sectional shape at a portionextending through the throughhole 628 to prevent rotation of the rod612. The housing 614 also includes a tube 630 and a guide 634 which hasthe shoulder 618. The tube is connected to the handle 606 by another setscrew 632.

Referring to FIG. 30, the distal end of the stapler 600 is shown. Thedistal end of the shaft 626 engages a staple pusher 636. The staples(not shown) are positioned in cavities 638 and are driven towardrecesses 640 in the anvil 616. The staple pusher 636 is slidably coupledto the guide 634 which guides the staple pusher 636 and defines thecavities 638 in which the staples are positioned. The guide 634 ispreferably coupled to the tube 630 by a compression fit but may beconnected to the tube 630 in any other manner. When the anvil 616 ismoved toward the proximal end by rotation of the actuator 602, thetissue layers are compressed between the anvil 616 and the shoulder 618of the guide 634 as will be described below in connection with FIG. 36.

Referring to FIG. 31, a cross-sectional view of FIG. 30 is shown alongline I--I. The guide 634 preferably includes at least five, and morepreferably at least six, cavities 638, however, any number of cavities638 may be provided. The staple pusher 636 includes staple drivers 642which are positioned in the cavities 638 and extend radially outwardlyfrom a central tube 644. Referring to FIG. 32, another cross-sectionalview of FIG. 30 is shown along line II--II. The recesses 640 of theanvil 616 are positioned and shaped to engage and deform the staplesbeing driven from the cavities 638 and have a cross-sectional shape asshown in FIG. 4. The cavities 638 and recesses 640 may have any otherconfiguration, including the tear drop shape of FIGS. 5 and 6, withoutdeparting from the scope of the invention.

Referring to FIGS. 33-34, a preferred staple 646 is shown. The staple646 includes a tissue compressing portion 648 extending between legs 449for compressing the tissue layers being stapled. The tissue compressingportion 648 has a height A of preferably 0.040 inches while the overallheight B of the staple is preferably 0.125 inches. The height A of thetissue compressing portion is preferably at least 15%, and morepreferably at least 25%, and most preferably at least 30% of the overallheight B of the staple 646. The tissue compressing portion 648 ispreferably solid between a top 650 and bottom 652 of the staple 646 sothat the staple 646 is more rigid, however, the tissue compressingportion 648 may also be hollow between the top 650 and bottom 652. Thebottom 652 of the tissue compressing portion 648 may also include tissueengaging features, such as atraumatic ridges, for securely grasping thetissue. The tissue compressing portion 648 permits controlledcompression of the tissue while the top 650 of the staple 646 is stillengaged by the staple pusher 636 for stability.

The staple 646 preferably includes a notch 654 which ensures that thelegs 649 bend at the desired location. The legs 649 preferably have awidth C of 0.010 inches. The sharp distal end of each leg is beveled atabout 45° and the notch 654 is preferably a distance D of 0.025 inchesfrom the sharp distal end. The notch 654 preferably has a radius ofcurvature of about 0.005 inches. Referring to FIG. 34, the staple 646preferably has a thickness E of 0.010 inches and a width F of 0.072inches. Although the dimensions given above are preferred, the staple646 may have any other dimensions without departing from the scope ofthe invention.

Operation of the stapler 600 is now described in connection withattaching a graft 660 to a blood vessel such as an aorta or a coronaryartery. Referring to FIG. 35, the rod 612 is detached from the stapler600 by rotating the actuator 602 until the rod 612 is decoupled from theactuator 602. The graft 660, which can be either synthetic or natural,is then fitted over the rod 612 with a suture 656 securing the proximalend of the graft 660 to the rod 612. The rod 612 is then reattached tothe actuator 602 so that the graft 660 is positioned almost entirelywithin the stapler 600.

Referring to FIG. 36, the distal end of the graft 660 is everted aroundthe shoulder 618. The anvil 616 is then pushed through the opening inthe body structure 662, which may be an aorta or a coronary artery, towhich the graft 660 is being attached. The actuator 602 is then rotatedto compress the body structure 662 and graft 660 between the anvil 616and shoulder 618 as shown in FIG. 37. An advantage of the stapler 600 isthat the compressive force on the graft 660 and body structure 662 maybe controlled independent of staple firing. Although it is preferred tomovably couple the anvil 616 to the handle 606, the anvil 616 may befixed to the handle 606 and the shoulder 618 may be movably coupled tothe handle 606 for compressing the tissue layers.

Referring still to FIG. 37, the trigger 604 is manipulated to drive thestaple pusher 636 and fire the staples 646. The staples 646 are forcedagainst the recesses 640 of the anvil 616 and buckle at the notches 654(FIG. 34). After the staples 646 have been fired, the actuator 602 isrotated to release compression of the tissue between the anvil 616 andshoulder 618. The anvil 616 and rod 612 are then removed from the graft660 and the other end of the graft 660 is attached to another bodystructure, such as an aorta or a coronary artery, thereby completing thegraft procedure.

Referring to FIG. 38, yet another stapler 700 is shown. The stapler 700includes similar features to the stapler 600 of FIGS. 29-37 and likereference numerals refer to like structure. The stapler 700 includes ahandle 706 having an actuator 702 at the proximal end. The actuator 702has a groove 708 which engages a set screw 710 for rotatably couplingthe actuator 702 to the handle 706. A rod 712 is threadably coupled tothe handle 706 so that rotation of the actuator 702 moves the rod 612proximally and distally. An anvil 716 is connected to the distal end ofthe rod 612. Rotation of the actuator 702 moves the anvil 716 towardsand away from a shoulder 718 of a housing 714 to control compression oftissue layers positioned therebetween as discussed above in connectionwith the stapler 600.

A trigger 704 is pivotally coupled to the handle 706 and actuation ofthe trigger 704 fires the staples (not shown). The trigger 704 engages adriver 720 which is biased toward the open position of FIG. 40 by aspring 722. A stop 724 limits rotation of the trigger 704 beyond theposition in FIG. 40. The driver 720 contacts and drives a shaft 726which extends toward the distal end. A tube 630 is also connected to thehandle 706 by another set screw 732.

The anvil 716 is expandable from the collapsed position of FIG. 39 tothe expanded position of FIG. 40. The anvil 716 is easier to withdrawthrough the graft after stapling is completed since the anvil 716 canassume the collapsed shape of FIG. 40. The expandable anvil 716 is movedfrom the collapsed shape to the expanded shape by an expander 717 whichextends through the rod 712. The expander 717 is coupled to a knob 719at the proximal end. The knob 719 is rotatably coupled to the actuator702 so that rotation of the knob 719 moves the expander 717 distally andproximally. The distal end of the expander 717 has a conical member 721which engages the anvil 716 to expand the anvil 716 as will be describedin greater detail below. The expander 717 preferably has a squarecross-sectional shape (not shown) at a portion 721 passing through thedistal end of the rod 712 with the distal end of the rod 612 having acomplementary shaped square throughhole 723. The square cross-sectionalshape of the expander 711 and throughhole 723 prevent rotation of theexpander 717 so that rotation of the knob 719 translates intolongitudinal motion of the expander 717.

A distal portion 725 of the rod 712 has a reduced diameter so that therod 712 is more flexible thereby permitting movement from the collapsedposition to the expanded position. Referring to FIG. 39, the distal endof the stapler 700 is shown. The distal end of the shaft 726 engages astaple pusher 736. The staples (not shown) are positioned in cavities738 and are driven toward recesses 740 in the anvil 716. The staplepusher 736 and guide 734 are the same as described above in connectionwith FIGS. 30-32.

Referring to FIG. 41, a cross-sectional view of FIG. 38 along lineIII--III is shown. The expander 717 and anvil 716 are shown with theanvil 716 in the collapsed position. The anvil 716 preferably has atleast four, more preferably at least five, and most preferably at leastsix anvil segments 716A. The rod 712 is split longitudinally along thedistal portion 725 (FIG. 38) into six corresponding rod sections 712A(FIG. 40) which each carry one of the anvil segments 716A. FIG. 40 showstwo of the rod segments 712A. The rod segments 712A act as springs whichpermit deflection of the distal portion of the rod 712. The rod segments712A bias the anvil segments toward the collapsed position of FIG. 39.Referring again to FIG. 41, the expander 717 includes ribs 731 whichengage slots 733 in the anvil segments 716A to ensure proper spacingbetween the anvil segments 716A and prevent displacement of the anvilsegments 716A when the staples are fired.

Referring to FIG. 42, a cross-sectional view of FIG. 39 along lineIV--IV is shown. The expander 717 is moved toward the proximal end sothat the larger diameter portion of the conical member 721 engages theanvil segments 716A and biases the rod segments 712A outwardly as shownin FIG. 39. Each of the anvil segments 716A include one of the recesses740 shown in FIG. 32 and the recesses 740 are positioned and shaped toengage and deform the staples being driven from the cavities 738 whenthe anvil 716 is in the expanded position. The anvil segments 716Apreferably have a plan area in the collapsed shape which is smaller thanthe plan area of the recesses when the anvil segments 716A are in theexpanded position so that the anvil segments 716A may be easilywithdrawn from the stapled area after stapling is completed. Thecavities 738 and recesses 740 may be in any other configuration, such asthe tear drop shape of FIGS. 5 and 6, without departing from the scopeof the invention. The stapler 700 preferably uses the staple 646described above in connection with FIGS. 34-36, however, any otherstaple may be used.

Operation of the stapler 700 is now described. The stapler 700 operatesin essentially the same as the stapler 600 except for use of theexpander 717. The rod 712 is alecoupled from the actuator 702 and theexpander 717 is decoupled from the knob 719. The rod 712 is then passedthrough the graft 760 with the anvil 716 in the collapsed shape. The rod712 and expander 717 are then reattached to the actuator 702 and knob719. The distal end of the graft 760 is everted around the distal end ofthe guide 734 and the anvil 716 is pushed through the opening in thebody structure to which the graft 760 is being attached. The knob 719 isthen rotated so that the expander 717 moves distally and expands theanvil 716 to the expanded position of FIG. 40. Alternatively, the anvil716 may be positioned in the expanded position before inserting theanvil 716 into the body structure. The actuator 702 is then rotated tocompress the body structure and graft between the anvil 716 and shoulder718. The trigger 704 is then actuated to drive the staple pusher 736 andfire the staples against the anvil segments 716A. After the staples havebeen fired, the actuator 702 is rotated to release compression of thetissue between the anvil 716 and shoulder 718 and the knob 719 isrotated to move the expander 717 distally thereby causing the anvilsegments 716A to move to the collapsed position. The anvil 716 and rod712 are then removed from the graft 760 and the other end of the graft760 is attached to another body structure, such as an aorta or acoronary artery, thereby completing the graft procedure.

It will be understood that the foregoing is only illustrative of theprinciples of the present invention, and that various modifications canbe made by those skilled in the art without departing from the scope andspirit of the invention. For example, the particular stapler structuralconfigurations shown are not critical and other configurations can beused if desired. One possible alternative for the configurationillustrated in FIG. 17 is to have a vessel rod that is retractable(e.g., by means of a telescoping rod). In addition, the vessel rod ofthis alternative embodiment can be curved to facilitate the anastomoticprocedure if necessary. Also, the structure and method of the presentinvention can be employed thoracoscopically.

What is claimed is:
 1. A stapler for stapling a tubular structure toanother structure, comprising:a body having a recess and a shoulder at adistal portion, the recess extending proximally from the shoulder, therecess being sized and configured to receive at least a portion of thetubular structure, the body also having a staple cavity extendingproximally from the shoulder; a staple positioned in the staple cavity;an anvil coupled to the body and being movable between an expandedcondition and a collapsed position; and a staple pusher movably coupledto the body for driving the staple from the staple cavity and againstthe anvil when the anvil is in the expanded position to staple thetubular structure to another structure.
 2. The stapler of claim 1,wherein:the shoulder is sized to receive an everted end of the tubularstructure which extends from the portion of the tubular structurecontained in the recess.
 3. The stapler of claim 1, wherein:the anvilhas a plurality of segments biased toward the collapsed position.
 4. Thestapler of claim 1, further comprising:an expander passing through theanvil and being slidably coupled to the anvil, the expander and anvilengaging one another with a rib and slot configuration, the rib and slotconfiguration being in engagement with one another when the anvil is inthe expanded position.
 5. The stapler of claim 1, further comprising:afirst actuator coupled to the body and configured to provide relativemovement between the anvil and the shoulder for compressing the tubularstructure and the another structure together between the anvil andshoulder; and a second actuator operably coupled to the staple pusherfor driving the staple toward the anvil.
 6. A stapler for surgicalstapling, comprising:a body having a shoulder at a distal portion and astaple cavity extending proximally from the shoulder; a staplepositioned in the staple cavity; an anvil coupled to the body andmovable between an expanded condition and a collapsed position, theanvil having a plurality of segments naturally biased toward thecollapsed position; a staple pusher movably coupled to the body fordriving the staple from the staple cavity and against the anvil when theanvil is in the expanded position to staple a structure to anotherstructure; and an expander slidably coupled to the anvil between a firstposition and a second position, the expander moving the anvil from thecollapsed position to the expanded position when the expander moves fromthe first position to the second position.
 7. The stapler of claim 6,wherein:the expander and anvil engage one another with a rib and slotconfiguration, the rib and slot configuration being in engagement withone another when the anvil is in the expanded condition.
 8. The staplerof claim 6, wherein:the body has a recess extending proximally from theshoulder, the recess being sized and configured to receive at least aportion of the structure to be stapled.